search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Pilot studie: Dystrofische signaalpaden in haarfollikels na chemotherapie


- candidate number15992
- NTR NumberNTR4343
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2014
- Secondary IDsNL45436.094.13 METC Noord-Holland
- Public TitlePilot studie: Dystrofische signaalpaden in haarfollikels na chemotherapie
- Scientific TitlePilot study: Dystrophic pathways in human hair follicles after chemotherapy
- ACRONYMPATH study
- hypothesisDamage response pathways can possibly explain the working mechanism of scalp cooling
- Healt Condition(s) or Problem(s) studiedChemotherapy, Scalp cooling, Alopecia, Pathway
- Inclusion criteria- Female patients with breast cancer
- Age 18 years or more
- Written informed consent
- Indication for at leaust one cycle of intravenous administered Docetaxel-Adriamycin-Cyclofosfamide (TAC), Fluorouracil-Epirubicin-Cyclophosphamide (FEC) or Adriamycin-Cyclophosphamide (AC).
- Exclusion criteria- Use of scalp cooling
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2013
- planned closingdate1-nov-2014
- Target number of participants10
- InterventionsThis pilot study will explore molecular damage-response pathways such as p53 expression in hair follicles after chemotherapy. It is known that all patients treated wit TAC, FEC and AC (any combination chemotherapy schedule including an anthracycline) lose their hair within two to three weeks. This pilot study explores various time-points to detect whether p53 fluctuates between these time-point. If there is no fluctuation between the different time-points in ten patients, it is unlikely to detect any fluctuation when more patients are included.
- Primary outcomeExpression of damage-response pathways
- Secondary outcomeNA
- TimepointsHair samples will be collected at different time points.
Hair samples will be collected at:
t=0 (before treatment with chemotherapy)
t=2 (two days after chemotherapy)
t=4 (four days after chemotherapy)
t=8 (eight days after chemotheray)
t=12 (twelve days after chemotherapy)
t=16 (sixteen days after chemotherapy)
The study will end when no fluctuation is seen between the different time-points.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. M.M.C. Komen
- CONTACT for SCIENTIFIC QUERIESMSc. M.M.C. Komen
- Sponsor/Initiator Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
Medisch Centrum Alkmaar
- PublicationsN/A
- Brief summaryAlopecia is an almost inevitable side effect of chemotherapy treatment. In cancer patients chemotherapy induced alopecia is experienced as one of the side effects with de most impact. Several factors may contribute to the severity of hair loss including dose, drug schedule, combinations with other cytotoxic agents as well as hair care practices. Research shows scalp cooling is an effective method to prevent chemotherapy induced hair loss. The exact working mechanism is unclear. Therefore we do not know why scalp cooling is effective in one patient but not in another.
The objective of this study is to explore molecular damage-response pathways such as p53 expression in hair follicles after chemotherapy.
The study will be conducted in the outpatient chemotherapy clinic of the department of internal medicine of the Medical Center Alkmaar. Patients will be asked to participate at the time of their first contact with the oncology nurse to schedule their first chemotherapy. After providing informed consent, hairs will be collected during the first chemotherapy course.
- Main changes (audit trail)
- RECORD6-jan-2014 - 19-feb-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl